Post-Coronavirus Disease of 2019 (COVID-19) Rehabilitation Clinics in Saudi Arabia

Post-COVID-19 Rehabilitation Clinics in Saudi Arabia: Improves Physical Status, Dyspnea, Fatigue, Anxiety, and Quality of Life

This intervention study aims to evaluate the before and after changes in physical fitness, cardiorespiratory status, exercise capacity, fatigue, anxiety, dyspnea, psychoemotional conditions, and quality of life through 3 sessions per week for 4-week of an intensive therapeutic program in post coronavirus survivors. In addition, it aims to answer the main questions before and after the clinical trial study.

• Does three sessions per week for 4-week of an intensive therapeutic program improve patients' physical fitness, cardiorespiratory status, and exercise capacity?
• Does it improve physical endurance and fitness, enhancing fatigue, anxiety, and dyspnea on post coronavirus patients? Participants will ask first to answer these questionnaires before and after the intervention.
• Berg Balance Scale (BBS): to assess the patient's ability (or inability) to safely balance (standing, active, and fall risk) during a series of planned tasks.
• The Modified Medical Research Council (mMRC) Dyspnea Scale: is used to assess patients' degree of baseline functional impairment due to dyspnea from respiratory diseases.
• Depression, Anxiety, and Stress Scale- 21 Items (DASS-21): measures the emotional states of depression, anxiety, and stress.
• Fatigue Assessment Scale (FAS): evaluates symptoms of chronic fatigue.
• Quality of Life (QOL)-short form-36: to assess the quality of life and calculate eight subscales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.

After answering the questionnaires, the patients will then go through multiple tests before and after the intervention:

• A 6-min walk test (6-MWT): is the primary measure of this study to assess aerobic capacity and endurance.
• 10-meter walk test (10MWT): assess walking speed in meters per second over a short distance and assess capacity and endurance.
• Time Up and Go (TUG) test: assess lower extremity function, mobility, and fall risk. The TUG test is the shortest, most straightforward clinical balance test available to predict the risk of falls.
• 1-min sit-to-stand test (1-MSTST): assess lower extremity strength for one minute.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue; Muscle Weakness; Stress, Emotional; Dyspnea; Physical Inactivity; Cardiopulmonary Arrest
• Intervention / Treatment: Other: Physical Therapy Rehabilitation

Detailed Description

The intervention will include all of the following exercises:

1. Breathing Exercises:

   • Breathing control:

     • Start with the breathing exercises at least twice a day, and increase to 4-6 times a day

     • Breathe in and out gently through the nose if possible.

     • If the breath is out through the mouth, the participant will instruct to purse their lips as if they are blowing out a candle
     • Attempt to release any tension in the body with each exhalation
     • Gradually try to make the breaths slower
     • Each participant will instruct to close their eyes to help focus on breathing and to relax

   • Deep breathing exercises

     • The participant will be instructed to take long, slow, and deep breaths through their nose and keep their chest and shoulders relaxed.
     • Breathe out gently and relax, like a sigh.
     • They should do three-five deep breaths.
     • Repeat for two minutes several times a day.

   • Huffing • A huff is exhaled through an open mouth and throat instead of coughing. It helps move sputum up the participants' airways so they can clear it in a controlled way.

     • To "huff," they must squeeze air quickly from their lungs through their open mouth and throat as if trying to mist up a mirror or glasses.
     • Use their abdominal muscles to assist them in squeezing out the air, but do not exert so much force that it causes wheezing or chest tightness.
     • If huffing clears their sputum, they should not need to cough. They should only cough if the sputum can clear quickly.
     • The participants should continue the breathing exercises for about 10 minutes, ideally until their chest feels clear of sputum.

2. Strengthening Exercises

   - To help restore muscle strength and increase endurance for 3 minutes daily.

   • Standing heel raise: hold on a chair, integrate arms reaching overhead when on toes. Repeat 2-3 times. Increase gradually to 8 Times (1-set)
   • Mini squats holding the chair with breathing
   • Wall push-ups hold for 8 seconds, then repetitions 2-3 times and increase to 10 repetitions.
   • For core exercises, start with 1-2 repetitions, then slowly increase to 10 repetitions.
   • Sit to stand and repeat 2-3 times. Increase gradually to 10-times

3. Mobility training or gait training

   - To increase endurance

   • Walk for at least 30 minutes without stopping five times per week
   • Start by walking on flat surfaces. As they progress and gain endurance, increase challenge by walking on hills and inclines for a 10-minute increase to 3 times a day.
   • Ascending and descending stairs with assistance if needed.
4. Home-exercise program (HEP) • All the activities above should continue at home

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asma A Alonazi, DSc; Phone Number: +966554447464; Email: a.alonazi@mu.edu.sa
• Study Contact Backup: Name: Abdullah K Alisamil, PhD; Phone Number: +1(909) 499-6811; Email: aalismail@llu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The participants' ages from 18-45 years old
• Participants who are referred to the post-COVID clinics
• Participants who are discharged from the hospitals within 3 to 6 months ago.

Exclusion Criteria:

• If they have any active infection such as pneumonia, cardiovascular instability, pulmonary embolism, and disability or disorders.
• Musculoskeletal disorders
• Neurodegenerative diseases
• Patients unable to walk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rehabilitation; The duration for 4-week, three sessions per week. Each session will last for 45-60 minutes	Other: Physical Therapy Rehabilitation; Physical Therapy Rehabilitation program to to establish a novel physiotherapeutic plan to determine the effects on post-COVID-19 patients' psychoemotional condition, lung capacity, cardiorespiratory condition, and muscle strength.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-min walk test (6-MWT)	Measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.	6 minutes
Time Up and Go (TUG) test	Measures the time needed to get up from a chair, walk 3 meters, and then return and sit back on a chair.	Less 1 minute
1-min sit-to-stand test (1-MSTST)	To stand up and sit down on a chair without arm rests as many times as possible within 1 min.	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-meter walk test (10MWT)	Measure used to assess walking speed in meters per second over a short distance of 14-meters.	10 minutes

Collaborators and Investigators

• Sponsor: Majmaah University
• Collaborators: King Fahad Medical City
• Investigators: Principal Investigator: Asma A Alonazi, DSc, Majmaah University, College of Applied Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical Therapy; Coronavirus disease; Respiratory function; 6-min walk test
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Signs and Symptoms, Respiratory; Fatigue; Muscle Weakness; Heart Arrest; Dyspnea
• Other Study ID Numbers: 22-472E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No